AggressivePhase 1NCT04648553
Task-Based Grounding Program
A Phase 1 study testing Task-Based Grounding and Connected Care (Enhanced Treatment as usual) in people with Aggressive and Defiant Disorder, Oppositional, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Aggressive, Defiant Disorder, Oppositional, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Task-Based Grounding and Connected Care (Enhanced Treatment as usual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 1 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of 18.
- The child must have a Vanderbilt Oppositional Defiant Disorder score >3
- The participating caregiver must be a legal guardian of participating child
- Exclusion Criteria (child refers to the primary participant's child)
- Child ever been hospitalized for a psychiatric problem
- Child ever attempted suicide or stated that they had a plan to attempt suicide within the past year.
Show all 11Show fewer
- Child ever engaged in self-harm behaviors
- Child has significant legal history such as adjudicated of a crime or been in diversion
- Child has ever been diagnosed with: Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Intellectual Disability or Developmental Delay, Speech or Hearing Delay, Autism Spectrum Disorder, Schizophrenia or another psychotic disorder, A substance abuse disorder (or had serious concerns about substance use).
- Parent can communicate in spoken English
- Parent is under the age of 18.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Pilot Randomized Control Trial of the Task-Based Grounding Program
The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. As phase 1 study, we are conducting a 2-arm pilot feasibility RCT in order the intervention, measures, and procedures to be used in a larger efficacy trial. The first arm will include a 3-session behavioral therapy treatment we call Task-Based Grounding and the second arm will be an enhanced treatment as usual comparison group.
Read the detailed description
The investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. The intervention uses telehealth visits along with written and online resources to teach them parent management skills. To evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. This is a mixed methods pilot feasibility RCT design. The investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. The investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. The treatment condition involves 3 telehealth visits and a set of parenting resources. The enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. Both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability.
- Being tested
- Task-Based Grounding, Connected Care (Enhanced Treatment as usual)
- Keywords
- Oppositional Defiant Disorder, Behavioral Parent Training
- Medical subject headings
- Aggression, Oppositional Defiant Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Based GroundingBehavioural
Three 50 minutes sessions with an interventionist that includes 6 non-punitive components of treatment common in Behavioral Parent Trainings: Education on behavior change, positive one-on-one time between parents and their children, differential attending to positive and negative behaviors, effective praise, giving effective instructions, and using a point and reward system to encourage prosocial behaviors. These components are distilled into 5 skill modules and paired with Task-Based Grounding, which involves a brief restriction of privileges and provides children with the opportunity to end the restriction by completing a prosocial task.
Connected Care (Enhanced Treatment as usual)Behavioural
Two sessions with a facilitator. The facilitator does NOT provide any guidance to the parent on managing their child's behavior, but provides empathy and problem solving to help them find a resource that best fits their needs. It is particularly geared towards helping parents connect with Behavioral Parent Trainings to address the needs of children with oppositional, defiant, or aggressive behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Task-Based Grounding | Experimental | Participating parents will be provided with three 50-minute Task Based Grounding sessions using a standardized manual over 6 weeks. Receives: Behavioral: Task-Based Grounding |
| Connected Care (Enhanced treatment as usual) | Sham comparator | Participating parents will be provided with two sessions and one phone check-in call over 6 weeks. They will work with a "care navigator" to assess their child's needs, find them an appropriate referral for care, and help problem solve barriers to finding a therapist. Receives: Behavioral: Connected Care (Enhanced Treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of referred participants
Feasibility of recruitment will be measured by number of participants referred
Measured: Through study completion, approximately 5 months.
Number of participants who screen positive
Feasibility of recruitment will be measured by number of participants who screen positive
Measured: Through study completion, approximately 5 months.
Change from Baseline Session attendance at visit 3
Feasibility of the participant retention in the program will be measured by session attendance by participants
Measured: Session attendance will be taken at Session 1 (week 0) and Session 3 (week 6)
Number of participants enrolled
Feasibility of recruitment will be measured by number of participants enrolled
Measured: Through study completion, approximately 5 months.
Number of participants who complete all assessment measures
Feasibility of assessment measures will be measured by number of participants who complete assessment measures
Measured: Through study completion, approximately 5 months.
Fidelity of the training provided
as measured by having a trained listener code and score fidelity using a checklist developed specifically for the content of each session. Audio recording of intervention sessions will be used. There are 35 items on the checklist, each worth 1pt. Score will be in terms of percentage, with a minimum score of 0 and a maximum score 100%.
Measured: Through study completion, approximately 5 months.
Intervention acceptability as measured by the Treatment Evaluation Inventory Short Form
as measured by Treatment Evaluation Inventory Short Form post intervention which measures intervention acceptance. The established cut off scores for determining if a treatment is acceptable is a score of 27. Min score possible is 0, max score possible is 32. Higher scores indicate greater acceptability.
Measured: Follow-up/post intervention (up to 10 weeks)
Intervention Acceptability as measured by the Therapy Attitude Inventory
as measured by the Therapy Attitude Inventory post intervention which measures acceptability of behavioral parent trainings. Min score of 1 is possible, max score of 50 is possible. Higher scores indicate greater acceptability.
Measured: Follow-up/post intervention (up to 10 weeks)
Intervention Acceptability as measured by the Participant Experiences Questionnaire
as measured by the Participant Experiences Questionnaire which measures acceptability of each skill module included in the program and is specific to program content. Min score of 0 possible, max score of 36 possible. Higher scores indicate greater acceptability.
Measured: Follow-up/post intervention (up to 10 weeks)
Acceptability as measured by qualitative interview
as measured by 30 minute semi-structured qualitative interview with participants conducted by a research assistant trained and supervised by the study PI
Measured: Follow-up/post intervention (up to 10 weeks)
Secondary outcomes (1)
Adherence to the intervention
as measured by daily logs that track both children's aggressive and defiant behaviors and parenting behaviors. A count of each time a parent used a skill from the program will be used to estimate adherence and assess whether they matched the appropriate skills to the reported misbehaviors.
Measured: Available for completion every day for 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start3 Dec 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James T. Craig, Dartmouth-Hitchcock Medical Center
- Investigators
- James T Craig, Ph.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648553
- Sponsor's protocol ID
- D21019
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Trial of the Task-Based Grounding Program
- ClinicalTrials.gov ID
- NCT04648553
- Acronym / sponsor ID
- D21019
- Keywords
- Oppositional Defiant Disorder, Behavioral Parent Training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. As phase 1 study, we are conducting a 2-arm pilot feasibility RCT in order the intervention, measures, and procedures to be used in a larger efficacy trial. The first arm will include a 3-session behavioral therapy treatment we call Task-Based Grounding and the second arm will be an enhanced treatment as usual comparison group.
Detailed description
The investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. The intervention uses telehealth visits along with written and online resources to teach them parent management skills. To evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. This is a mixed methods pilot feasibility RCT design. The investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. The investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. The treatment condition involves 3 telehealth visits and a set of parenting resources. The enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. Both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-Based Grounding | Experimental | Behavioral: Task-Based GroundingParticipating parents will be provided with three 50-minute Task Based Grounding sessions using a standardized manual over 6 weeks. |
| Connected Care (Enhanced treatment as usual) | Sham comparator | Behavioral: Connected Care (Enhanced Treatment as usual)Participating parents will be provided with two sessions and one phone check-in call over 6 weeks. They will work with a "care navigator" to assess their child's needs, find them an appropriate referral for care, and help problem solve barriers to finding a therapist. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of 18.
- The child must have a Vanderbilt Oppositional Defiant Disorder score >3
- The participating caregiver must be a legal guardian of participating child
- Exclusion Criteria (child refers to the primary participant's child)
- Child ever been hospitalized for a psychiatric problem
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-Based GroundingThree 50 minutes sessions with an interventionist that includes 6 non-punitive components of treatment common in Behavioral Parent Trainings: Education on behavior change, positive one-on-one time between parents and their children, differential attending to positive and negative behaviors, effective praise, giving effective instructions, and using a point and reward system to encourage prosocial behaviors. These components are distilled into 5 skill modules and paired with Task-Based Grounding, which involves a brief restriction of privileges and provides children with the opportunity to end the restriction by completing a prosocial task. | Behavioural | Task-Based Grounding |
| Connected Care (Enhanced Treatment as usual)Two sessions with a facilitator. The facilitator does NOT provide any guidance to the parent on managing their child's behavior, but provides empathy and problem solving to help them find a resource that best fits their needs. It is particularly geared towards helping parents connect with Behavioral Parent Trainings to address the needs of children with oppositional, defiant, or aggressive behaviors. | Behavioural | Connected Care (Enhanced treatment as usual) |
Primary outcome
Number of referred participants
Time frame: Through study completion, approximately 5 months.
Feasibility of recruitment will be measured by number of participants referred
Number of participants who screen positive
Time frame: Through study completion, approximately 5 months.
Feasibility of recruitment will be measured by number of participants who screen positive
Change from Baseline Session attendance at visit 3
Time frame: Session attendance will be taken at Session 1 (week 0) and Session 3 (week 6)
Feasibility of the participant retention in the program will be measured by session attendance by participants
Number of participants enrolled
Time frame: Through study completion, approximately 5 months.
Feasibility of recruitment will be measured by number of participants enrolled
Number of participants who complete all assessment measures
Time frame: Through study completion, approximately 5 months.
Feasibility of assessment measures will be measured by number of participants who complete assessment measures
Fidelity of the training provided
Time frame: Through study completion, approximately 5 months.
as measured by having a trained listener code and score fidelity using a checklist developed specifically for the content of each session. Audio recording of intervention sessions will be used. There are 35 items on the checklist, each worth 1pt. Score will be in terms of percentage, with a minimum score of 0 and a maximum score 100%.
Intervention acceptability as measured by the Treatment Evaluation Inventory Short Form
Time frame: Follow-up/post intervention (up to 10 weeks)
as measured by Treatment Evaluation Inventory Short Form post intervention which measures intervention acceptance. The established cut off scores for determining if a treatment is acceptable is a score of 27. Min score possible is 0, max score possible is 32. Higher scores indicate greater acceptability.
Intervention Acceptability as measured by the Therapy Attitude Inventory
Time frame: Follow-up/post intervention (up to 10 weeks)
as measured by the Therapy Attitude Inventory post intervention which measures acceptability of behavioral parent trainings. Min score of 1 is possible, max score of 50 is possible. Higher scores indicate greater acceptability.
Intervention Acceptability as measured by the Participant Experiences Questionnaire
Time frame: Follow-up/post intervention (up to 10 weeks)
as measured by the Participant Experiences Questionnaire which measures acceptability of each skill module included in the program and is specific to program content. Min score of 0 possible, max score of 36 possible. Higher scores indicate greater acceptability.
Acceptability as measured by qualitative interview
Time frame: Follow-up/post intervention (up to 10 weeks)
as measured by 30 minute semi-structured qualitative interview with participants conducted by a research assistant trained and supervised by the study PI
1 secondary outcome
Adherence to the intervention
Time frame: Available for completion every day for 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Craig, Ph.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Task-Based Grounding and Connected Care (Enhanced Treatment as usual) in people with Aggressive and Defiant Disorder, Oppositional, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of referred participants (time frame: Through study completion, approximately 5 months.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.